Innova Nasal Non Vented Mask, s/m

GUDID 00814747020791

Nasal non vented mask for use with non invasive ventilator system with exhalation valve.

SLEEPNET, CORP.

CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use
Primary Device ID00814747020791
NIH Device Record Key44a85689-a443-488e-8ec3-d849bf2da046
Commercial Distribution Discontinuation2019-04-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameInnova Nasal Non Vented Mask, s/m
Version Model Number50592
Company DUNS785635186
Company NameSLEEPNET, CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814747020791 [Primary]
GS100814747021897 [Primary]

FDA Product Code

BYGMask, Oxygen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-04-24
Device Publish Date2016-06-07

On-Brand Devices [Innova Nasal Non Vented Mask, s/m]

00814747020791Nasal non vented mask for use with non invasive ventilator system with exhalation valve.
00814747022610Nasal non vented mask for use with CPAP/bilevel positive pressure systems with exhalation valves

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